The European Union’s Medical Device Regulation (MDR) entered into application on May 21, 2021, replacing a regulatory framework for devices dating back to the 1990’s and consolidating three directives into two new regulations.
The MDR introduces new or revised responsibilities for manufacturers, distributors, and regulatory affairs and quality management professionals involved with bringing medical devices to market in the European Union, including the establishment of requirements related to unique device identification.
Medical devices play a fundamental role in improving health and saving lives. The European Commission estimates there are over 500,000 types of medical devices and in vitro diagnostic medical devices (IVDs)1 on the EU market. These range from sticking plasters and contact lenses to x-ray machines, pacemakers, hip replacements and even software applications.
The medical device regulation, (EU) 2017/745 (MDR), brings EU legislation in line with technical advances, changes in medical science and progress in law-making made since the old directives came into force, and, the commission says, creates a robust, transparent, and sustainable regulatory framework, recognised internationally, for improving clinical safety and creating fair market access for manufacturers and healthcare professionals. Reflecting technological innovation for example, the revised MDR recognises that devices are increasingly combined with pharmaceuticals, biopharmaceuticals and other substances to assist with the diagnosis, prediction, prevention, monitoring, prognosis, treatment or alleviation of disease.
Implementation of a Unique Identification System
The EU database system for medical devices (EUDAMED), has necessitated the inclusion of a unique device identification (UDI) system, which is intended to facilitate easier traceability of medical devices , enhance the effectiveness of post-market safety-related activities, and facilitate monitoring by competent authorities.
Briefly, the UDI system requires that the manufacturer, importer or distributor:
- Creates a UDI incorporating a UDI device identifier (UDI-DI) and UDI production identifier (UDI-PI) that together identify the manufacturer, device, unit of device production and associated packaging
- Places of the UDI carrier on the label of the device, on its packaging or, in case of reusable devices, through direct marking on the device itself
- The UDI specifies storage throughout the supply chain and by healthcare institutions is in accordance with conditions specified for the device (e.g., humidity, sterility, shelf-life)
- Maintains an electronic database for UDI’s (the ‘UDI database’), which is part of the EUDAMED database.
Use of the UDI system should also improve purchasing, stock management, and waste disposal procedures through the supply chain and in health institutions, but perhaps its most important goals are to reduce medical errors and inhibit the proliferation of counterfeit or unapproved devices.
Moving forward together
In contrast to the European Commission’s Directives, its Regulations do not need to be transposed into national law, so the MDR reduces the risks of discrepancies in interpretation across the EU market.
Transitional periods have been planned to smooth the application of the new regulations, with the provisions related to the designation of Notified Bodies and the ability of manufacturers to apply for new certificates under the MDR. The European Parliament later adopted an extension of the transition period for the EU MDR [2]. The key changes include:
Extension of the transitional period for higher-risk devices (class III and certain class IIb implantable devices) such as pacemakers to comply with EU MDR requirements until Dec. 31, 2027
Extension of the transitional period for medium and lower-risk devices (other class IIb devices, class IIa, class Im, Is and Ir devices) such as needles and syringes to comply with EU MDR requirements until Dec. 31, 2028
These extensions are subject to certain conditions, including requirements for market surveillance, quality management systems, and engagement with notified bodies.
Throughout the transition period, several publications have been made available to support MDR implementation. These include guidance on exemptions from the requirements to perform clinical investigations, updates on questions and answers regarding clinical investigations, and updates on importers and distributors.
MDR implementation at Terumo Europe
Terumo Europe received its first certificate under EU-MDR on May 29, 2020, ahead of other manufactures. This covered four product categories including Nanopass, a pen needle for the subcutaneous injection of insulin.
The company accelerated its efforts to acquire further certifications and to strengthen its operation to deliver safe medical devices worldwide, and the following products are now also certified: K-Pack II, Neolus, Surflo Winged Infusion Sets, Syringes with fixed needles
Terumo Europe has completed the following actions:
- Technical documentation and quality management system in line with MDR requirements
- Certification has been obtained after a successful audit by the notified body
- MDR implementation in production was done gradually in the course of 2023.
We are ready to support our customers with MDR implementation.
A word on Brexit…
The United Kingdom withdrew from the European Union in February 2020, and the UK government has since announced it intends to introduce new regulations for medical devices. A transition period has been agreed that will extend the acceptance of CE marked medical devices on the Great Britain market until June 30, 2030. The UK government expects to put in place priority measures to enhance post-market surveillance, in 2024, with core elements of the new UK framework expected to be in place in 2025 [4].
A safer, efficient, and unified solution
As a core player in the EMEA healthcare market that manufactures within and imports devices into the EU, Terumo Europe has taken steps to proactively comply with the new regulations, including by implementing a UDI carrier on the primary packaging of its entire product portfolio, including the examples shown earlier. Terumo Europe had previously implemented a UDI carrier on primary packaging for products sold under US FDA regulation. In accordance with the MDR, quality system procedures had to be updated and audited by a Notified Body for compliance with the regulation.
The new medical device regulation has required manufacturers, importers, and distributors to consider carefully how to implement important and far-reaching new features such as the UDI system, but their ongoing commitment as technology solutions partners has helped Terumo Europe ensure full compliance of its product portfolio to the latest regulations.
The MDR has brought valuable reform that better reflects decades of innovation since the EU’s last directive, and particularly reflects the diversity of medical devices available on the market today. Through the use of a common reference in the UDI that also sets out storage conditions, the MDR provides the opportunity for manufacturers, the distribution network, and healthcare institutions to better control stockholding and reduce waste. Most importantly, by helping to ensure that medical devices are fit for purpose and by limiting proliferation of non-compliant and counterfeit devices, the MDR, and its companion regulation for in vitro diagnostic medical devices, provides a strong framework for protecting patients for many years to come.
